MAUDE Adverse Event Report: STELKAST INC. CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM

Model Number SC3458-52

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned.

Event Description

Inner ring of the cross-over acetabular shell became dislodged from the shell after impaction.Another acetabular shell of the same part number was implanted successfully.

• Brand Name: CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM
• Type of Device: CROSS-OVER ACETABULAR SHELL
• Manufacturer (Section D): STELKAST INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer (Section G): STELKAST INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer Contact: john reyher ; 200 hidden valley road; mcmurray, PA 15317 ; 7249416368
• MDR Report Key: 6801152
• MDR Text Key: 82944460
• Report Number: 2530191-2017-00102
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC3458-52
• Device Lot Number: 34440250525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR